3 New Lawsuits Challenge The FDA’s Approval Rules
3 new lawsuits, filed simultaneously on Tuesday in three different federal jurisdictions, challenge the FDA’s Rule of Deeming. Complaints were filed by Pacific Law Foundation lawyers on behalf of several small Vaping companies. The Deeming Regulation (also known as the Deeming Regulation) entered into force on 8 August 2016. The provision allows the FDA to regulate electronic cigarettes and vapors as tobacco products, and forces manufacturers to keep a very expensive process and to keep expensive products on the market that were not sold before February 15, 2007.
Prior to this date, there were no products available. This means that every Vape product, including all e-liquids currently on the market, must go through the FDA Premarket Tobacco Application (PMTA) to be available for sale after August 8, 2022. The date was changed last year by the FDA. Originally, the date was scheduled for August 8, 2018.
The new lawsuits challenge the FDA on 2 fronts. First, Pacific Legal Foundation (PLF) attorneys say regulations such as the final assignment rule must be signed by Federal officials appointed by the President and endorsed by the Senate. The Deeming Rule was signed by a career officer, Assistant Commissioner Leslie Kux.
“These rules not only hurt small businesses and consumers, they undermine the constitutional guarantees of individual freedom. The rules that affect the American people must be issued by officials who respond to the political process rather than by bureaucrats who have no political responsibility,” said PLF lawyer Thomas Berry in a Press Release.
The lawsuits also challenge freedom of expression, claiming that companies confine themselves to honestly explaining the benefits of Vaping customers.
“The Vaping Edict violates the First Amendment by forcing companies to create a difficult regulatory glove to publish accurate information. The government cannot demand the prior approval of a truthful speech, and above all, it cannot transfer the burden of proof to the speaker to show that the benefit of his speech is greater than any damage the government suffers.” reads the PLF Website.
Other legal challenges to the allocation rule are still pending before several federal courts. Best known is the Nicopure Labs lawsuit (which was combined with the application of the Coalition Law to the Non-Smoke and several other industry associations), which was rejected by Judge Amy Berman Jackson.
The Vaping has appealed in this case, and Nicopure and its allies expect a result this year. PLF procedures and possible appeals could take years. Meanwhile, just a week after Nicopure’s decision, FDA Commissioner Scott Gottlieb promised standards-based regulation last year.
One of the PLF cases was filed with the same court as the US District Court of Nicopure for the District of Columbia. The others will be heard in the federal district courts of Minnesota and Texas. There may be a legal strategy to force the FDA to defend its unpopular authority in several courts, but it is unclear.
So, who is the Pacific Legal Foundation, and why are you interested in Vaping? According to their website, the PLF is “a group of people united in our conviction that personal freedom is essential to a prosperous society.”
The Foundation is a libertarian group of public law that fights against what it considers an excessive government. Founded in 1973 by Ronald Reagan employees, it is the oldest conservative legal group of its kind. It is a non-profit organization 501(c)(3). The PLF has always defended private property rights and challenged environmental regulations affecting homeowners. It also fought against the laws of positive action that favor racial or gender attitudes.
“Governments at all levels undermine freedom by enacting laws that interfere with the right of people to freely associate and express themselves, to acquire and use property, or to earn a sane livelihood. It is daunting for the average person to defend these rights against the government, with their power and access to significant resources, that’s where we come in.” says the site.
The cold demonstration of power by the FDA in the “Regulation” of the small independent Vaping industry certainly goes through all PLF boxes. And almost all Vapers agree that the calculation rule of the agency should disappear, be it from the political right, from the left or from the center.